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Figure 1.

Participant Flow

Each box represents the flow of participants through the study, from screening to enrollment to randomization and analysis. AE, adverse event necessitating withdrawal from study; WD, individual withdrew from study (see text).

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Table 1.

The Demographics of the Study Participants Showed Equal Distribution among All Treatment Groups

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Figure 2.

Plasma [HIV] during Steps II and III of Individuals According to Immunotherapy Treatment Group

Red vertical line in center of each figure depicts the demarcation between Step II and Step III. Fractions in upper right corner of each figure portray the number of participants who were eligible to enter Step III in each group.

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Figure 3.

Results from Interim Analysis

This was a 2×2 factorial study with participants randomized to receive vaccine (+) or not (−), and IL-2 (+) or no-IL-2 (−). The numbers listed in each block are the mean plasma [HIV] log10 RNA copies/ml for each participant from the last 5 weeks of Step II (i.e., weeks 21–25). There was no significant difference between the means of each group based on a 2×2 ANOVA.

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Figure 4.

Mean CD8+ and CD4+ T cell Concentrations of the Four Immunotherapy Groups during Step II

(A) CD8+ T cells.

(B) CD4+ T cells.

Blue diamonds = group A, placebo; red squares = group B, vaccine; green triangles = group C, IL-2; black circles = group D, IL-2 + vaccine. Brackets depict SEM.

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Figure 5.

Mean HIV p55 gag-Specific T Cells Capable of Producing IFN-γ According to Treatment Group

(A) [CD8+ T cell].

(B) [CD4+ T cell].

Brackets depict SEM. Bkg, background.

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Figure 6.

Mean HIV p55 gag-Specific T Cells Capable of Producing TNF-α According to Treatment Group

(A) [CD8+ T cell].

(B) [CD4+ T cell].

Brackets depict SEM. Bkg, background.

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Figure 7.

Mean HIV p55 gag-Specific T Cells Capable of Producing IL-2 According to Treatment Group

(A) [CD8+ T cell].

(B) [CD4+ T cell].

Brackets depict SEM. Bkg, background.

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Figure 7 Expand

Table 2.

Adverse Events above Grade I

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